BOOSTRIX-IPV 0.5 mL injection syringe

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

Diphtheria toxoid, Quantity: 2 IU; Pertussis toxoid, Quantity: 8 microgram; Tetanus toxoid, Quantity: 20 IU; Pertactin, Quantity: 2.5 microgram; Pertussis filamentous haemagglutinin, Quantity: 8 microgram; Poliovirus, Quantity: 32 AgU

Доступна с:

GlaxoSmithKline Australia Pty Ltd

Фармацевтическая форма:

Injection, suspension

состав:

Excipient Ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin B sulfate; glucose monohydrate; ascorbic acid; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

Администрация маршрут:

Intramuscular

Штук в упаковке:

Pack of 10 pre-filled syringe, Pack of 1 pre-filled syringe

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

BOOSTRIX-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,BOOSTRIX-IPV is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION, Section 4.6 FERTILITY, PREGNANCY AND LACTATION and 5.1 PHARMACODYNAMIC PROPERTIES).,The NHMRC currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,For those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,The NHMRC currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dTpa at 15 to 17 years of age. Before the eighth birthday, DTP-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. After the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dTpa or dT-containing vaccines) should be given.,A booster dose of dTpa is also recommended:,? Before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? For adults working with young children,? For any adult expressing an interest in receiving a booster dose of dTpa, provided that a primary course of DTP vaccine has been given in the past.,Clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given BOOSTRIX-IPV (see Section 5.1 PHARMACODYNAMIC PROPERTIES).,Finally, all adults who reach the age of 50 years without having received a boosting dose of dT in the previous 5 years should receive a further boosting dose of dT, where the adult/adolescent formulation dTpa can be used instead.,BOOSTRIX-IPV is not intended for primary immunisation.

Обзор продуктов:

Visual Identification: Turbid liquid, white deposit, colourless supernatant; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Registered

Дата Авторизация:

2004-07-08

тонкая брошюра

BOOSTRIX-IPV
1
BOOSTRIX-IPV
_Combined diphtheria-Tetanus-acellular pertussis (dTpa) and
Inactivated Poliovirus Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using BOOSTRIX-
IPV.
This leaflet answers some common
questions about BOOSTRIX-IPV. It
does not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the risks of you receiving
BOOSTRIX-IPV against the
expected benefits they expect it will
have.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING BOOSTRIX-IPV, ASK
YOUR DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE VACCINE.
You may need to read it again.
WHAT BOOSTRIX-IPV
IS USED FOR
BOOSTRIX-IPV is a vaccine used as
a booster to prevent four diseases,
diphtheria, tetanus, pertussis
(whooping cough) and poliomyelitis
(polio) in adults and children aged 4
years and older who have been
previously vaccinated against these
diseases. The vaccine works by
causing the body to produce its own
protection (antibodies) against these
diseases.
Diphtheria, tetanus, and pertussis are
all serious life-threatening diseases
caused by bacterial infection.
Poliomyelitis is an infectious disease
caused by viral infection.
DIPHTHERIA
Diphtheria mainly affects the airways
and sometimes the skin. Generally
the airways become inflamed
(swollen) causing severe breathing
difficulties and sometimes
suffocation. The bacteria also release
a toxin (poison), which can cause
nerve damage, heart problems, and
death. The risk of serious
complications and death is greater in
the very young and elderly.
TETANUS (LOCKJAW)
Tetanus bacteria enter the body
through wounded skin. Wounds that
are especially prone to infection are
burns, fractures, deep wounds or
wounds contaminated with soil, dust,
horse manure or wood splinters. The
bacteria release a toxin (poison),
which can cause muscle stiffness,
painful muscle spasms, fits and
death. The spasms

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION
BOOSTRIX-IPV (COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS
(DTPA) AND INACTIVATED POLIOVIRUS) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Combined diphtheria, tetanus, acellular pertussis (dTpa) and
inactivated poliovirus vaccine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BOOSTRIX-IPV is a sterile suspension for injection which contains
diphtheria toxoid (D),
tetanus toxoid (T), three purified antigens of Bordetella pertussis
[pertussis toxoid (PT),
pertussis filamentous haemagglutinin (FHA) and pertactin (PRN)] and
three types of
inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1
strain; type 3: Saukett
strain).
1 dose (0.5 mL) contains:
Diphtheria toxoid
1
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid
1
not less than 20 International Units (IU) (5 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid
1
8 micrograms
Filamentous Haemagglutinin
1
8 micrograms
Pertactin
1
2.5 micrograms
Inactivated poliovirus
type 1 (Mahoney strain)
2
40 D-antigen unit
type 2 (MEF-1 strain)
2
8 D-antigen unit
type 3 (Saukett strain)
2
32 D-antigen unit
1
adsorbed on aluminium hydroxide hydrate (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
2
propagated in VERO cells
The manufacture of this product includes exposure to bovine derived
materials. No
evidence exists that any case of vCJD (considered to be the human form
of bovine
spongiform encephalopathy) has resulted from the administration of any
vaccine product.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
2
3
PHARMACEUTICAL FORM
BOOSTRIX-IPV is a turbid white suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BOOSTRIX-IPV is indicated for booster vaccination against diphtheria,
tetanus, pertussis
and polio of individuals from the age of four years onwards.
BOOSTRIX-IPV is also indicated for passive protection against
pertussis in early infancy
following maternal immunisation during pregnancy (see Section 4.2 DOSE
AND METHOD
OF ADMI